CDSCO License for Telemetric diagnostic spirometer

Comprehensive Guide to CDSCO Licensing for Telemetric Diagnostic Spirometers (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having assisted 500+ manufacturers and importers, we understand the unique challenges faced when navigating the CDSCO licensing landscape in India. This guide focuses specifically on the Telemetric Diagnostic Spirometer, a battery-powered portable Class B medical device used in rehabilitation to measure key pulmonary function parameters and transmit data remotely.

Understanding the Telemetric Diagnostic Spirometer and Regulatory Importance

A Telemetric Diagnostic Spirometer is designed to assess respiratory-gas volumes and flow parameters such as vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF). It enables healthcare professionals to remotely monitor pulmonary function, making it an essential tool in respiratory rehabilitation.

Given its role in patient diagnosis and management, this device falls under Class B risk category as per CDSCO, requiring stringent regulatory oversight to ensure safety, efficacy, and compliance with Indian standards.

CDSCO Regulatory Framework for Telemetric Diagnostic Spirometer

The Central Drugs Standard Control Organization (CDSCO) governs medical device registration and licensing in India. For Class B devices, the manufacturing license is issued by the State Licensing Authority under the MD5 License scheme. Importers require the MD15 Import License issued by the Central Licensing Authority.

This regulatory framework ensures devices meet essential principles of safety and performance before entering the Indian market.

Risk Classification and License Requirements for Class B Devices

As per CDSCO's classification:

• Class B devices are considered low-moderate risk.
• They require a Manufacturing License (MD5) granted by the State Licensing Authority.
• The process includes obtaining a Test License (MD13) initially, product testing by government-approved laboratories, followed by inspection audits by notified bodies.

For more on classification, refer our Medical Device Classification guide.

Manufacturing License Process for Telemetric Diagnostic Spirometers (MD5 License)

The manufacturing license process involves the following key steps:

1. Apply for Test License (Form MD13): Before full manufacturing license application, a test license is mandatory to conduct product testing. Processing takes about 1.5 to 2 months.

2. Product Testing: Conduct testing at CDSCO-approved labs listed here. Tests verify compliance with Indian standards.

3. Documentation Preparation: Compile essential documents including Device Master File, Plant Master File, and Quality Management System documents.

4. Apply for Manufacturing License (Form MD3): Submit application for MD5 license via the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit is conducted by a notified body selected from the official Notified Bodies List.

6. Queries & Clarifications: Address any queries raised by CDSCO or the notified body promptly.

7. Grant of Manufacturing License (Form MD5): Upon satisfactory review and audit compliance, the license is issued.

Manufacturing License Documents Required for Telemetric Diagnostic Spirometers

The following documents must be submitted:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualification and Experience Details of Technical Staff
• Fire and Pollution NOCs
• Device Master File (DMF): Detailed device description, design, and manufacturing process (Learn more)
• Plant Master File (PMF): Details of manufacturing infrastructure (Detailed guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating risk assessment and mitigation (More on Risk Management)
• Test Reports from CDSCO-approved laboratories
• Labels, Instructions for Use (IFU)
• Quality Management System Documents (typically ISO 13485:2016 certified)

Import License Process (MD15) for Telemetric Diagnostic Spirometers

If importing the device into India, an MD15 import license from CDSCO is mandatory. The process includes:

• Preparation of requisite documentation
• Submission of application in Form MD14 via the CDSCO MD Online Portal
• Resolution of departmental queries
• Grant of Import License (Form MD15)

Note that for Class B devices, import license fees and timelines vary; the process generally takes 5-6 months. For detailed steps, consult our Import License guide.

Import License Documents Required

Required documents include:

• Valid Manufacturing License (MD5/MD9) from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License for distribution
• Company Constitution and Importer details

Timeline and Processing Duration for MD5 License (Class B Device)

Total Estimated Duration: Approximately 3 to 4 months from test license application to grant of manufacturing license.

Government Fees and Costs

• Test License (MD13): Nominal application fee (varies by state)
• MD5 Application Fee: Rs 5,000 per application + Rs 500 per product
• Product Testing: Costs depend on laboratory and number of tests; budget approximately Rs 50,000 - Rs 1,00,000
• Audit Fees: Payable to the selected notified body (varies, typically Rs 1,00,000+)

Planning a realistic budget upfront will help avoid unexpected expenses.

Common Challenges and Solutions

• Delayed Testing Results: Choose CDSCO-approved laboratories with capacity to handle your product to avoid bottlenecks.

• Incomplete Documentation: Use comprehensive checklists and consult experts to ensure all files (DMF, PMF, Risk Management) are robust.

• Audit Non-Compliance: Prepare thoroughly by conducting internal audits and training staff to meet notified body standards.

• Query Resolution Delays: Respond promptly and provide clear, detailed information to regulatory queries.

Expert Consultation and Support

With our extensive experience assisting over 500 companies, we offer:

• Tailored document preparation support for DMF, PMF, and Risk Management files
• Guidance through product testing and lab selection
• Coordination with notified bodies for seamless audits
• End-to-end application submission and query management

Our proven track record ensures faster approvals and smoother regulatory journeys.

Getting Started with Your CDSCO License Application for Telemetric Diagnostic Spirometer

1. Evaluate your device classification and licensing needs: Confirm Class B status and required MD5 test license.

2. Prepare essential files: Develop your Device Master File and Plant Master File early; refer to our DMF guide and PMF guide.

3. Select a CDSCO-approved testing laboratory: Visit the official Testing Laboratories list.

4. Submit your Test License application (MD13) through the CDSCO MD Online Portal.

5. Plan your audit schedule: Choose your notified body from the Notified Bodies list and prepare the facility accordingly.

6. Engage expert regulatory consultants: Leverage experienced partners to navigate complexities and accelerate approvals.

Embarking on your CDSCO licensing journey with a clear roadmap and expert guidance will position your Telemetric Diagnostic Spirometer for successful market entry in India.

For detailed assistance, reach out to our expert team who can tailor solutions specific to your device and business goals.